Collection systems for endoscopic surgical procedures

ABSTRACT

A collection system for collecting substances within the body in endoscopic operative procedures wherein access to a site in the body is obtained through a narrow portal in the body includes an elongate inner tubular member, an elongate outer tubular member receiving the inner tubular member, a collection bag carried by a distal end of the inner tubular member and a suction cutter disposed in the inner tubular member. The collection bag has a non-expanded position wherein the collection bag is disposed within the outer tubular member to facilitate introduction of distal ends of the outer and inner tubular members through the narrow portal. The collection bag is movable from the non-expanded position to an expanded position within the body, the collection bag in the expanded position being disposed externally of the outer tubular member to allow substances to be introduced in the collection bag. The suction cutter has a distal end disposed within the collection bag, a proximal end and a suction channel between the distal and proximal ends of the suction cutter. The suction channel is connectible with a source of suction externally of the body to withdraw the substances introduced in the collection bag while the collection bag remains in the body.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a divisional of prior application Ser. No.08/287,007, filed Aug. 8, 1994 and now U.S. Pat. No. 5,556,376, which isa continuation-in-part of patent applications Ser. No. 08/045,768, filedApr. 14, 1993 and now U.S. Pat. No. 5,451,204, Ser. No. 07/600,775,filed Oct. 23, 1990 and now U.S. Pat. No. 5,374,261 and Ser. No.07/596,937, filed Oct. 15, 1990 and now abandoned, Ser. No. 08/045,768being a continuation-in-part of Ser. No. 07/789,599, filed Nov. 8, 1991and now abandoned, Ser. No. 07/789,599 being a divisional of Ser. No.07/556,081, filed Jul. 24, 1990 and now U.S. Pat. No. 5,074,840, Ser.No. 07/600,775 being a continuation-in-part of Ser. No. 07/556,081 andSer. No. 07/596,937 being a continuation-in-part of application Ser. No.07/222,776, filed Jul. 22, 1988 and now abandoned. The foregoing patentapplications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to endoscopic surgery and, moreparticularly, to devices and methods for use in endoscopic surgery toperform various functions including creating or increasing the size of aspace in the body, aspiration, irrigation, wiping, cleansing,manipulating or retracting tissue or organ structures, separatingadhering tissue (lysis of adhesion), dissecting tissue, isolating tissueto be treated, protecting surrounding tissue, increasing visibility forthe surgeon, collecting substances in the body and miniaturizingcollected substances.

2. Description of the Prior Art

Endoscopically performed operative procedures are preferred for surgeryon the human body due to their least invasive nature and reduced traumaand tissue damage as compared with open surgery. While endoscopicallyperformed operative procedures are preferred, there are obstacles toexpanding endoscopy to include the various procedures currentlyperformed with open surgery. For example, endoscopic procedures are muchmore difficult and dangerous to perform where tissue or organ structurecannot be adequately exposed and manipulated, surrounding tissue andorgan structure cannot be protected during the operative procedure andfluids cannot be removed from the operative site. Additionally, in manyendoscopic procedures, there is little or no space by which to accessthe operative site and introduce and maneuver instruments. Furthermore,in many endoscopic procedures, it is extremely difficult to accomplishfacilitating procedures including tissue retraction and manipulation,cleansing, wiping, lysis of adhesion, tissue dissection, collectionand/or miniaturization of fluids and/or tissue samples, tissuecoagulation and irrigation and/or aspiration.

SUMMARY OF THE INVENTION

Accordingly, it is a primary object of the present invention to improvethe efficacy and safety of endoscopic operative procedures.

Another object of the present invention is to expand the types ofprocedures that can be performed endoscopically.

An additional object of the present invention is to facilitateendoscopic procedures with a multifunctional device having a portioncapable of being deployed in a loop configuration upon introduction ofthe portion in the body to perform various diverse functions.

It is also an object of the present invention to provide a method offacilitating the performance of endoscopic procedures including thesteps of introducing a loop forming portion of a multifunctional devicein the body in a non-deployed position and moving the loop formingportion, from externally of the body, to a deployed position forming aloop configuration.

Another object of the present invention is to facilitate endoscopicprocedures with a collection system having a collection bag for beingintroduced in the body through a narrow portal to allow substances to beplaced in the interior of the collection bag for removal from the body.

Some of the advantages of the present invention include improvedvisibility in endoscopic procedures, reduced need for insufflation,improved exposure of operative sites, protection of surrounding tissueand organ structure, irrigation and/or aspiration or drainage, cleansingof debris, stones, pus and other substances, such as fluids released bya ruptured appendix, bowel or cyst, allowing expansion of an absorbentmaterial to greater sizes within the body, facilitating introduction andwithdrawal of the devices through a narrow portal, reducing orpreventing the undesirable release into the body of substances collectedby the multifunctional devices, collecting substances within the bodyand miniaturizing the collected substances simultaneously andwithdrawing collected substances from the body.

These and other objects, advantages and benefits are realized with thepresent invention as characterized in a multifunctional device for usein endoscopic procedures in the body including an elongate outer member,an elongate inner member and a loop forming portion connected betweenthe outer member and the inner member for being introduced in the body.The loop forming portion is movable from a non-deployed positionfacilitating introduction in the body to a deployed position forming aloop configuration within the body for performing many variousprocedures. The loop configuration of the loop forming portion in thedeployed position can be utilized to collect substances in the body, andthe loop forming portion can be made of an absorbent material forabsorbing substances in the body. The loop forming portion is movable,from externally of the body, to squeeze absorbed or collected substancesfrom the loop forming portion.

A method of facilitating the performance of endoscopic operativeprocedures according to the present invention includes the steps ofintroducing the loop forming portion in the body in the non-deployedposition, moving the loop forming portion from externally of the body tothe deployed position, performing an operative procedure with the loopforming portion, moving the loop forming portion to the non-deployedposition from externally of the body and withdrawing the loop formingportion from the body.

A collection system according to the present invention includes acollection bag for being introduced in the body and being movable, fromexternally of the body, from a non-expanded position facilitatingintroduction in the body to an expanded position in the body allowingsubstances to be introduced in the interior of the collection bag. Alumen coupled with the interior of the collection bag and connectablewith a source of suction allows substances deposited in the interior ofthe collection bag to be withdrawn from the body.

Other objects and advantages of the present invention will becomeapparent from the following description of the preferred embodimentstaken in conjunction with the accompanying drawings wherein like partsin each of the several figures are identified by the same referencecharacters.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a broken side view, partly in section, of a multifunctionaldevice according to the present invention.

FIG. 2 is a broken, side sectional view of a distal portion of themultifunctional device of FIG. 1 in a non-expanded position.

FIG. 3 is a broken, side sectional view of the distal portion of themultifunctional device of FIG. 1 in an expanded position forming a loopconfiguration.

FIG. 4 is an end view of the distal portion of the multifunctionaldevice of FIG. 1 in the expanded position.

FIG. 5 is a broken side view, partly in section, of the distal portionof the multifunctional device of FIG. 1 in a twisted state.

FIG. 6 is a broken side view of a collection system according to thepresent invention.

FIG. 7 is a broken, side sectional view of a distal portion of thecollection bag assembly of the collection system of FIG. 6.

FIG. 8 is a broken, fragmentary side view of the inner member andcollection bag of the collection bag assembly of FIG. 7.

FIG. 9 is a broken side view, partly in section, of the suction cutterassembly of the collection system of FIG. 6.

FIG. 10 is a broken, side sectional view of a distal portion of thecollection system of FIG. 6 with the collection bag in an expandedposition.

FIG. 11 is a broken perspective view illustrating use of the collectionsystem in combination with a multifunctional device according to thepresent invention.

FIG. 12 is a broken side view of a modification of a multifunctionaldevice according to the present invention.

FIG. 13 is a broken side view, partly in section, of a distal portion ofthe multifunctional device of FIG. 12 showing attachment of a strip tothe inner and outer members of the multifunctional device.

FIG. 14 is a broken side view of the distal portion of themultifunctional device of FIG. 12 in the expanded position.

FIG. 15 is a broken perspective view of a strip and spine for themultifunctional device of FIG. 12.

FIG. 16 is a broken side view of the spine of FIG. 15.

FIG. 17 is a broken side view of the distal portion of themultifunctional device of FIG. 12 in an adjusted position.

FIG. 18 is a schematic top view of an adjustment system for themultifunctional devices according to the present invention.

FIG. 19 is a perspective view of the adjustment system of FIG. 18 incombination with the inner member of the multifunctional device of FIG.12.

FIG. 20 is a broken side view of the distal portion of anothermodification of a multifunctional device according to the presentinvention in an expanded position.

FIG. 21 illustrates the distal portion of FIG. 20 with some of thestrips broken away.

FIG. 22 is a broken side view, partly in section, of the distal portionof a further modification of a multifunctional device according to thepresent invention in the expanded position.

FIG. 23 is a broken side view, partly in section, of the distal portionof an additional modification of a multifunctional device according tothe present invention in the expanded position.

FIG. 24 is a broken side view, partly in section, of anothermodification of a multifunctional device according to the presentinvention in the expanded position with one of the strips detached toform a protruding probe.

FIG. 25 is a broken side view of a modification of a multifunctionaldevice in combination with a suction cutter assembly according to thepresent invention.

FIG. 26 is a broken side view, partly in section, of the distal portionof a modification of a suction cutter assembly according to the presentinvention.

FIG. 27 is a broken, side sectional view of the distal portion of FIG.26.

FIG. 28 is a broken side view, partly in section, of a modification of ahandle assembly for use in the present invention.

FIG. 29 is a broken side view of another modification of a handleassembly for use in the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A multifunctional device 10 in accordance with the present invention isillustrated in FIG. 1 and includes an elongate outer member 12, anelongate inner member 14 disposed in outer member 12, a loop or mopforming portion 16 connected between the outer member 12 and the innermember 14 and a handle assembly 18 mounting the outer member 12 and theinner member 14. Outer member 12 terminates distally at a distal end 20connected with loop forming portion 16 and proximally at a transverseflange 22 at a proximal end of the outer member mounted to handleassembly 18. Outer member 12 has an internal lumen or passagetherethrough for receiving the inner member 14 with a close fit tominimize the cross-sectional size of the multifunctional device 10 tofacilitate introduction through a narrow portal while permittingrelative movement of one or both of the outer member 12 and the innermember 14. Outer member 12 can be made of any suitable rigid,semi-rigid, flexible or bendable medical grade material and can have anydesirable size and configuration in cross-section, including tubular andnon-tubular cross-sectional configurations, in accordance withprocedural use.

Inner member 14 can be made of any suitable rigid, semi-rigid, flexibleor bendable medical grade material and can have any desirable size andconfiguration in cross-section to be received in the lumen or passage ofouter member 12. Inner member 14 terminates distally at a distal end 24connected with loop forming portion 16 and proximally at a proximal endmounted to handle assembly 18. The inner member 14 carries or forms anactuating knob 26 and a transverse flange 28 disposed distally ofactuating knob 26 for mounting the inner member 14 to the handleassembly 18 as explained further below. Inner member 14 includes aninternal lumen or passage 29 therethrough allowing fluids and/or variousmedical instruments to be passed through device 10. One or both of theouter member 12 and the inner member 14 is mounted for movement in afirst direction relative to the other of the outer member 12 and theinner member 14. In addition, one or both of the outer member 12 and theinner member 14 can be mounted for movement in a second direction,different than the first direction, relative to the other of the outermember 12 and the inner member 14. In the multifunctional device 10,both the outer member 12 and the inner member 14 are longitudinallymovable distally and proximally relative to one another for movement ina first direction, and at least the inner member 14 is mounted forclockwise and/or counterclockwise rotational movement relative to theouter member 12 for movement in a second direction as accomplished viamanual rotation of actuating knob 26. Actuating knob 26 can have anydesirable configuration; and, preferably, actuating knob 26 isconfigured to be accessed and operated by the hand grasping handleassembly 18. As shown in FIG. 1, actuating knob 26 is in the nature of acircumferential transverse shoulder or ring having external ridgesthereon to facilitate rotation by the surgeon's thumb.

Loop forming portion 16 includes one or more strips, strands or strings30, each of which has a first end connected to the distal end 20 ofouter member 12 and a second end connected to the distal end 24 of innermember 14. The loop forming portion 16 can be made of an absorbentmaterial for absorbing substances such as fluids and/or bodily tissue,or the loop forming portion 16 can be made of a non-absorbent materialincluding a resilient, flexible, stretchable, expandable or bendablemembrane. As shown, the loop forming portion 16 for the multifunctionaldevice 10 includes a plurality of strips 30 made of an absorbentmaterial. The strips 30 can be made of an expandable material or anon-expandable material, and the strips 30 can be expandable in sizeupon absorption of fluids such that the cross-sectional size of thestrips in a wet state upon absorbing fluids in the body is greater thanthe cross-sectional size of the strips in a dry state prior to absorbingfluids. The material selected for strips 30 can vary in accordance withthe rigidity and configuration desired for loop forming portion 16 in adeployed position; and, accordingly, the strips 30 can be soft or floppyor somewhat hard and rigid. The strips 30 can be covered individuallywith a flexible, resilient, stretchable, expandable or bendable membraneor the loop forming portion 16 in whole or in part can be covered withor formed by a flexible, resilient, stretchable, expandable or bendablemembrane. Strips 30 can be provided with various therapeutic substances,such as medicaments or coagulating agents, and such substances can becarried on the surfaces or within the material of the strips 30. Thesurfaces of strips 30 can be smooth or irregular or rough depending onprocedural use.

Strips 30 for device 10 have their first ends attached to acircumferential peripheral edge of outer member 12 at the distal end 20thereof at closely spaced locations about a longitudinal axis of outermember 12. The second ends of strips 30 are attached to acircumferential peripheral edge of inner member 14 at the distal end 24thereof at closely spaced locations about a longitudinal axis of theinner member 14 corresponding to the locations along outer member 12.The strips 30 can be arranged on the outer and inner members in manyvarious ways in accordance with the configuration desired for loopforming portion 16 in the deployed position, and the strips 30 can beattached to the outer and inner members at different, non-correspondinglocations. The ends of strips 30 can be connected or attached to theouter and inner members in many various ways including adhesively or viaretention of the ends of strips 30 in recesses in the walls of the outerand inner members as shown in FIG. 13.

Some or all of the strips 30 can be designed to assume a predeterminedconfiguration in the deployed position. The strips 30 can be designed inmany various ways to have a predetermined configuration in the deployedposition. For example, strips 30 can be made of a material having ashape memory or a spine can be provided for guiding the strips 30 to thepredetermined configuration. Examples of various spine members suitablefor use in the present invention are disclosed in applicant's priorapplications incorporated herein by reference. Where a spine isutilized, the spine can be hollow, tubular or provided with an internalpassage for aspiration and/or delivery of substances, such asmedicaments, to and from the body via the spine.

Handle assembly 18 includes a generally U-shaped handle having a distalhandle arm 32 and a proximal handle arm 34 connected by a curved springsegment 36. The handle arms 32 and 34 and the spring segment 36 can bemade as separate components pivotally connected to one another, or thehandle arms 32 and 34 and the spring segment 36 can be made integrally,unitarily as shown in FIG. 1. Distal handle arm 32 carries a collar 38having a recess therein for mounting the outer member proximal flange22. Proximal handle arm 34 carries a collar 40 having a recess thereinfor mounting the transverse flange 28 of the inner member 14 with theinner member 14 passing through aligned openings in the collars 38 and40. The handle assembly 18 can be designed to be permanently connectedto the outer member 12 and the inner member 14, or the handle assembly18 can be designed to be removable or detachable from the outer member12 and the inner member 14. Relative displacement of the handle arms 32and 34 via squeezing thereof causes relative longitudinal movement ofouter member 12 and inner member 14, and a locking mechanism 42 can beprovided in handle assembly 18 to fix the relative position of thehandle arms 32 and 34.

Locking mechanism 42 includes a locking bar 44 pivotally mounted at oneend to proximal handle arm 34 by a hinge, pivot or joint 46. The lockingbar 44 extends through a slot 48 in distal handle arm 32 to terminate ata downwardly angled operating lever 50, and the locking bar 44 isrotationally biased toward an upper end of slot 48 by a torsion spring(not shown) at joint 46. A plurality of locking teeth 52 are disposed onan upper surface of locking bar 44 along the length thereof forcooperative engagement with locking teeth 54 formed in distal handle arm32 along an upper wall of slot 48. Locking teeth 52 are angledproximally to permit movement of handle arms 32 and 34 toward oneanother in response to squeezing operation of handle assembly 18, andlocking teeth 54 are configured to prevent movement of handle arms 32and 34 away from one another upon termination of the squeezing force.

An inlet assembly 56 is coupled or formed with the inner member 14 andincludes a hollow member, such as tube 58, coupled with the lumen 29 ofinner member 14 and a valve 60 for opening and closing the lumen 29 ofthe inner member 14 to allow fluid flow and/or instruments to be passedtherethrough when the valve 60 is open and to close off or seal thelumen 29 when the valve 60 is closed. Valve 60 can have any desirableconstruction; and, as shown in FIG. 1, valve 60 includes a ball-cockvalve along tube 58. The inlet assembly 56 can be formed separately frominner member 14 in which case tube 58 can extend into the lumen 29 ofinner member 14, or the inlet assembly 56 can be formed integrally,unitarily with inner member 14 in which case tube 58 can be formed as anextension of the inner member 14 as shown for device 10. Where the inletassembly 56 is formed separately from the inner member 14, the inletassembly 56 can be coupled to inner member 14 in many various ways toprevent rotation of inlet assembly 56 when the inner member 14 isrotated relative to the outer member 12, or the inlet assembly 56 can beallowed to rotate with the inner member 14.

The multifunctional device 10 is normally supplied as shown in FIG. 1with handle arms 32 and 34 biased away from one another by springsegment 36 to position the distal end 20 of outer member 12 and thedistal end 24 of inner member 14 such that the loop forming portion 16is in a non-deployed position. As shown for the multifunctional device10, the handle assembly 18 is designed to normally position the innermember distal end 24 proximally of the outer member distal end 20 adistance substantially corresponding to the length of strips 30.Accordingly, loop forming portion 16 is biased to the non-deployedposition with strips 30 in a substantially straight or straightconfiguration extending lengthwise or longitudinally within outer member12 between the outer member distal end 20 and the inner member distalend 24 parallel or substantially parallel with a longitudinal axis ofmultifunctional device 10. Therefore, a distal portion of themulti-functional device 10 has a substantially uniform cross-section inthe non-deployed position facilitating introduction in the body througha narrow portal.

When it is desired to utilize the multifunctional device 10 inendoscopic operative procedures, the distal portion of themultifunctional device 10 in the non-deployed position is introduced inthe body through a relatively narrow portal, which can include astructural channel such as a portal sleeve or cannula, an incisionalopening or a natural entry opening providing access through ananatomical wall, such as an anatomical cavity wall W as shown in FIG. 2wherein the device 10 is introduced through a portal sleeve S. In thenon-deployed position, handle arms 32 and 34 will be held in place bylocking bar 44 preventing relative longitudinal movement of outer member12 and inner member 14, and the cross-sectional size of the distalportion of multifunctional device 10 will be substantially uniform tofacilitate introduction through the narrow portal. Once the distalportion of the multifunctional device 10 is positioned in the body, suchas in the anatomical cavity or in tissue within or forming theanatomical cavity, handle arms 32 and 34 disposed externally of the bodyare manually squeezed causing the handle arms 32 and 34 to be movedtoward one another against the bias of spring segment 36 as permitted bythe proximal angle of teeth 52 and the torsion spring at joint 46.Movement of handle arms 32 and 34 via squeezing operation of handleassembly 18 causes outer member 12 and inner member 14 to movelongitudinally relative to one another. Accordingly, the outer memberdistal end 20 and the inner member distal end 24 will be moved towardone another causing the loop forming portion 16 to be moved to thedeployed position illustrated in FIGS. 3 and 4. Movement of handle arms32 and 34 is controlled via locking teeth 52 and 54 with cooperativeengagement of the locking teeth 52 and 54 maintaining the handle arms 32and 34 and, therefore, the outer member 12 and inner member 14, in adesired position upon termination of the squeezing force on the handleassembly 18.

In the deployed position, strips 30 are folded or bent to form a loop ormop configuration at the distal portion of multifunctional device 10. Asshown in FIGS. 3 and 4, loop forming portion 16 forms a multiple loopconfiguration with strips 30 protruding distally beyond the outer memberdistal end 20 and curving or bending inwardly to extend proximally tothe inner member distal end 24 which remains within the outer member 12.The loops formed by strips 30 in the deployed position are disposedabout the longitudinal axis of the multifunctional device 10 allowingfluid flow and/or instruments to be introduced in the body through theinlet assembly 56 and the lumen 29 of inner member 14. In the deployedposition, the multiple loop or mop structure defined by loop formingportion 16 can be used to perform various functions including creatingor increasing the size of a space within the body, absorption ofsubstances such as fluids and tissue by the material of strips 30 orcollection of substances within the recesses formed by the loops,cleansing of debris, stones, pus and other materials, such as materialsreleased by a ruptured capsule or organ including a ruptured cyst,appendix or bowel, manipulating or retracting tissue or organstructures, separating adhering tissue, dissecting tissue, isolatingtissue to be treated, protecting surrounding tissue and increasingvisibility for the surgeon.

The loop forming portion 16 has a predetermined configuration in thedeployed position forming an enlargement or protrusion at the distalportion of device 10 having a cross-sectional size greater than thecross-sectional size of the distal portion of device 10 prior todeployment of the loop forming portion 16. As shown for multifunctionaldevice 10, the enlargement formed by loop forming portion 16 protrudesoutwardly in a direction transverse to the longitudinal axis of themultifunctional device 10. The size and configuration of the loopforming portion 16 can be changed or varied during use by selectivelyextending and/or retracting the loop forming portion 16 via operation ofhandle assembly 18. When it is desired to retract loop forming portion16 further into outer member 12 in a partially deployed position or tomove loop forming portion 16 to the non-deployed position, operatinglever 50 is grasped, preferably by a finger of the hand grasping thehandle assembly 18, and is moved downwardly against the upwardrotational bias of the torsion spring at joint 46 to disengage teeth 52from teeth 54. With the locking teeth 52 and 54 disengaged, springsegment 36 will urge handle arms 32 and 34 away from one another causingrelative movement of the outer and inner members to move loop formingportion 16 toward the non-deployed position. The lever 50 can bereleased at any time to reengage teeth 52 with teeth 54 thusly fixingthe position of handle arms 32 and 34 and, therefore, loop formingportion 16. Upon return of the loop forming portion 16 to thenon-deployed position, the multifunctional device 10 can be withdrawnfrom the body through the narrow portal.

Prior to withdrawal of the multifunctional device 10 from the body,fluids and/or tissue absorbed or collected by loop forming portion 16can be removed therefrom by manually rotating the actuating knob 26causing the inner member 14 to be rotated relative to the outer member12. Rotation of inner member 14 relative to outer member 12 causes thestrips 30 to be twisted in a wringing action to assume a twisted statethusly squeezing fluids and/or other materials from the loop formingportion 16 as shown in FIG. 5. The loop forming portion 16 can betwisted or wrung when in the non-deployed position or when in thedeployed position as shown in FIG. 5. Where it is undesired for thefluids or tissue wrung from loop forming portion 16 to be released intothe body, the multifunctional device 10 can be utilized with acollection system as described further below, or the inner member distalportion can be provided with holes as illustrated in FIG. 21 forwithdrawal of the fluids or tissue through lumen 29 when suction isapplied via inlet assembly 56. Squeezing or wringing to remove absorbedor collected substances allows the loop forming portion 16 to be reusedduring the course of the procedure being performed for furtherabsorption and/or collection and permits the size of the loop formingportion to be reduced facilitating return to the non-deployed positionand/or withdrawal from the body through the narrow portal.

The outer member 12, the inner member 14 and the handle assembly 18 canbe designed in many various ways to normally position the outer memberdistal end 20 and the inner member distal end 24 in accordance with thestructure of the loop forming portion 16 such that the distal portion ofthe device 10 has a substantially uniform cross-section in thenon-deployed position to facilitate introduction in the body through anarrow portal. The arrangement of strips 30 in the non-deployed positioncan vary depending on the initial position of the outer and innermembers and/or the configuration of strips 30 and the manner in whichthe strips 30 are attached to the outer and inner members. Varioushandle assemblies can be utilized with the multifunctional devices ofthe present invention to effect relative longitudinal and rotationalmovement of the outer member and/or the inner member, and themultifunctional devices can be formed of two or more elongate members.One or both of the outer member and the inner member can be mounted forrotation; and, as shown in FIG. 1, the outer member proximal flange 22can form or be connected with an actuating knob 23 disposed externallyof collar 38 for rotating the outer member 12 relative to the innermember 14 as guided by the recess of collar 38.

The multifunctional devices according to the present invention can beutilized in endoscopic procedures in many various areas of the bodyincluding abdominal, joint, orthopedic, gastrointestinal, spinal, bone,sinus, vascular, uterine and gall bladder cavities, for example. Themultifunctional devices according to the present invention areparticularly useful to create a space from a nonexisting space or from apotential space in the body or to create or increase the size of anyarea or space in the body to carry out endoscopic diagnostic and/ortherapeutic procedures. Various devices can be introduced in the bodythrough the lumen of the inner member including suction cuttinginstruments, suture needles, needle holders, clips and clip appliers,ring and string applicators, sponge sticks, dissecting probes, scissors,biopsy forceps, and holding or grasping instruments. Various substances,including medicaments, irrigating fluids and bodily fluids, can beintroduced in and withdrawn from the body via the multifunctionaldevices. The outer member and/or inner member can be provided withvarious adjustment systems or controls, such as wires, for adjusting orchanging the direction or orientation of the loop forming portion withinthe body.

FIG. 6 illustrates at 62 a collection system particularly useful withthe multifunctional devices of the present invention to collect fluidsand/or other materials, such as solid materials, released from the loopforming portion prior to withdrawal of the multifunctional devices fromthe body. The collection system 62 includes a collection bag assembly 64and a suction cutter assembly 66. As shown in FIGS. 6 and 7, collectionbag assembly 64 includes an elongate outer member 68, an elongate innermember 70 disposed in outer member 68 and a collection bag 72. Outermember 68 terminates distally at a distal end 76 and proximally at anenlarged, transverse flange or shoulder 78. Outer member 68 includes aninternal lumen or passage therethrough for receiving the inner member 70with a close fit to minimize the cross-sectional size of the collectionsystem for introduction through a narrow portal while permittingrelative longitudinal movement of one or both of the outer member 68 andthe inner member 70. The outer member 68 can be made of any suitablerigid, semi-rigid, flexible or bendable medical grade material and canhave any desirable size and configuration in cross-section, includingtubular and non-tubular cross-sectional configurations, to be introducedin the body through the narrow portal. Inner member 70 can be made ofany suitable rigid, semi-rigid, flexible or bendable medical gradematerial and can have any desirable size and configuration incross-section to be received in the lumen or passage of outer member 68.Inner member 70 terminates distally at a distal end 80 and proximally atan enlarged, transverse flange or shoulder 82. The inner member 70 hasan internal lumen or passage therethrough for receiving a suction cutterof the suction cutter assembly 66 as explained further below.

Collection bag 72 is arranged in the assembly 64 to be movable betweenan expanded position and a non-expanded or collapsed position inresponse to longitudinal movement of outer member 68 and/or inner member70. Collection bag 72 for assembly 64 is carried by the inner member 70and includes a single layer or multiple layers of material configured tohave a forward or distal end and a rearward or proximal end attached toinner member 70. Collection bag 72 can be made of any desirable medicalgrade material, such as fluid-proof plastic, to be movable orcollapsible from the expanded position as shown in FIG. 7 to thenon-expanded or collapsed position wherein the collection bag 72 isdisposed within the outer member 68 as shown in FIG. 6. The collectionbag 72 can be attached to the inner member 70 in many various ways, suchas adhesively or mechanically including the use of various bonds orseals. As shown in FIG. 8, bag 72 includes a rearward or proximal edge84 received within a circumferential recess 86 at the distal end 80 ofthe inner member 70 with the recess 86 being disposed within thethickness of the wall forming the inner member 70. Accordingly, whenattached to inner member 70, bag 72 defines an enclosed or substantiallyenclosed space or interior communicating with the internal passage orlumen of the inner member 70. Bag 72 includes an access slot or opening73 in a side wall thereof communicating with the interior of bag 72 andwith the lumen of inner member 70. The access slot or opening 73 can beprovided with a slide closure or zipper 75 operable by an operating tab77 to selectively close the opening 73 as shown in dotted lines in FIG.7 and to selectively open the opening 73 to permit positioning of loopforming portion 16 in bag 72. Bag 72 can have various sizes andconfigurations in the expanded position in accordance with proceduraluse, and the bag 72 can be biased toward the expanded position. The bag72 can be biased toward the expanded position in many various ways, suchas by forming the bag of a material having a shape memory or with theuse of a mechanical, shape-retaining reinforcement or a spine.

FIG. 7 illustrates a spine 74 for moving collection bag 72 to theexpanded position and for permitting the collection bag 72 to be movedto the non-expanded or collapsed position. Spine 74 is carried by theinner member 70 and includes a plurality of arms 88 attached to thedistal end 80 of inner member 70 at spaced locations about alongitudinal axis of the inner member 70. The spine 74 includes fourarms 88 attached to the inner member 70 at 90° spaced locations aboutthe inner member longitudinal axis, only three arms 88 being visible inFIG. 7. Arms 88 extend distally from the inner member 70 and are biasedin a direction outwardly of or transverse to a longitudinal axis of theinner member to be normally disposed in an expanded position as shown inFIG. 7. Spine 74 can be biased in many various ways to be normallydisposed in the expanded position and to be movable to a non-expanded orcollapsed position by outer member 68 when the spine 74 is disposed inthe outer member 68.

Outer member 68 and inner member 70 are longitudinally movable relativeto one another by squeezing operation of flanges 78 and 82 to move spine74 and, therefore, bag 72, from the non-expanded position wherein bag 72and spine 74 are disposed in outer member 68 to the expanded positionwherein bag 72 and spine 74 are disposed distally of outer member 68. Alocking mechanism can be provided for fixing the relative positions offlanges 78 and 82 and, as shown in FIG. 6, includes a locking bar 131pivotally mounted at one end to flange 82 by a joint, pivot or hinge133. The locking bar 131 is rotationally biased toward flange 78, i.e.,clockwise looking at FIG. 6, by a torsion spring (not shown) at joint133. A plurality of locking teeth 135 are disposed on an upper surfaceof locking bar 131 along the length thereof for cooperative engagementwith ridges 137 on flange 78. Locking teeth 135 are angled proximally topermit movement of flanges 78 and 82 toward one another in response tosqueezing operation thereof, and ridges 137 are configured to preventmovement of flanges 78 and 82 away from one another upon termination ofthe squeezing force. The end of locking arm 131 opposite joint 133terminates at an angled operating lever 139 for disengaging teeth 135from ridges 137 to permit movement of flanges 78 and 82 away from oneanother. Where it is desired for the collection bag 72 to be biased tothe collapsed position within outer member 68, various springs or otherbias devices can be provided between flanges 78 and 82 to bias the outermember 68 distally and/or the inner member 70 proximally.

Suction cutter assembly 66 is best illustrated in FIG. 9 and includes asuction cutter having an elongate outer member 90, an elongate innermember 92 disposed within outer member 90 and a handle assembly 94mounting the outer member 90 and inner member 92. Outer member 90 can bemade of any suitable medical grade material having sufficient rigidityand strength for cutting anatomical tissue and terminates distally at adistal portion 96, a part of which is broken away in FIG. 9, andproximally at a proximal end 98 mounted to handle assembly 94. Outermember 90 can have various cross-sectional configurations and sizes,including a tubular configuration as shown, to be received within thelumen of the inner member 70 of collection bag assembly 64 and includesa lumen or internal passage for receiving inner member 92. A cuttingedge 100 is defined on the distal portion 96 for cutting anatomicaltissue in cooperation with a cutting edge on the inner member 92. Thecutting edge 100 can have various configurations to cooperate with thecutting edge on the inner member 92; and, as shown, cutting edge 100includes a plurality of longitudinally aligned circular cutting edges100 defined along wall surfaces of the outer member 90 circumscribingapertures 102 in the wall of the outer member 90 communicating with thelumen or internal passage thereof.

Inner member 92 can be made of any suitable medical grade material withsufficient rigidity and strength to cut anatomical tissue and terminatesdistally at a distal portion 104, a part of which is broken away in FIG.9, and proximally at a proximal end 106 mounted to handle assembly 94.The inner member 92 can have various cross-sectional configurations andsizes to cooperate with outer member 90 and to be received in the lumenof the outer member with a close fit while permitting relativelongitudinal and/or rotational movement of one or both of the outermember 90 and the inner member 92. The inner member 92 includes a lumenor internal passage 93 therethrough allowing flow of fluids and othermaterials through the suction cutter, and a cutting edge 108 is definedon the distal portion 104 for cooperating with the cutting edge 100 onouter member 90. As shown, the cutting edge 108 includes a plurality oflongitudinally aligned circular cutting edges 108 defined along wallsurfaces of the inner member 92 circumscribing apertures 111 in the wallof the inner member 92 communicating with the lumen 93. Cutting edge 108is designed to cooperate with cutting edge 100 to cut anatomical tissuevia relative rotation of one or both of the cutting edges 100 and 108and/or relative longitudinal movement of one or both of the cuttingedges 100 and 108.

Handle assembly 94 mounts the outer member 90 and the inner member 92 tonormally position the apertures 102 and 111 and, therefore, the cuttingedges 100 and 108 in alignment to form a scalloped cutting edge as shownin FIG. 9. The handle assembly 94 can incorporate various structure orcomponents to permit manual and/or electrically powered longitudinaland/or rotational movement of one or both of the outer member 90 and theinner member 92. The handle assembly 94 for suction cutter assembly 66is manually operated and includes a generally U-shaped handle, similarto the handle of handle assembly 18, having a distal handle arm 113 anda proximal handle arm 115 connected by a curved spring segment 117.Distal handle arm 113 carries a collar 119 secured to the proximal end98 of the outer member 90. The proximal handle arm 115 carries a collar121 having a recess therein for mounting a transverse flange 141 on theinner member 92 with the inner member 92 passing through alignedopenings in the collars 119 and 121. The inner member 92 is coupled withor forms an inlet assembly 125 including a tube coupled with the lumen93 of the inner member 92 and a valve 127 for opening and closing thelumen 93 to allow fluid flow and/or instruments to be passedtherethrough when the valve is open and to close off or seal the lumen93 when the valve 127 is closed. The inlet assembly 125 is similar toinlet assembly 56 and can be formed integrally with the inner member 92as shown in FIG. 9 or separately therefrom. The outer member 90 andinner member 92 are movable longitudinally relative to one another viamanual squeezing operation of handle arms 113 and 115; and,additionally, the inner member 92 is manually rotatable within the outermember 90 via rotation of an actuating knob 143 on inlet assembly 125.

When it is desired to utilize the collection system 62, the suctioncutter assembly 66 is assembled with the collection bag assembly 64 asshown in FIG. 6 with the bag 72 in the non-expanded position.Accordingly, flanges 78 and 82 are spaced from one another to positionthe inner member distal end 80 proximally of the outer member distal end76 such that bag 72 and spine 74 are disposed within the outer member 68with the flanges 78 and 82 held in place by locking bar 131. In thenon-expanded position, spine 74 is collapsed within outer member 68 witharms 88 disposed parallel or substantially parallel with one another andwith a longitudinal axis of the collection bag assembly 64, and bag 72is collapsed around spine 74. To assemble the suction cutter assembly 66with the collection bag assembly 64, the outer member 90 of the suctioncutter is disposed in the lumen of the inner member 70 of the collectionbag assembly 64. With a forward end of collar 119 in abutment withflange 82, the scalloped cutting edge formed by the aligned cuttingedges 100 and 108 will be disposed within the collection bag 72 with thecutting edges 100 and 108 being maintained in alignment by handle arms113 and 115 as positioned by spring segment 117. If desired, thecollection bag assembly 64 can be removably secured to the suctioncutter assembly 66, such as by a pivotable or rotatable detent or clamp145 for removably locking the flange 82 to the collar 119. The arms 88of spine 74 and the collection bag 72 will be collapsed about the distalportion 96 of the suction cutter assembly, and the collection system 62will be ready for use with the outer member 68 providing a smooth,uniform profile for introduction in the body through a narrow portal.

When the collection system 62 is utilized in combination with themultifunctional devices of the present invention, such asmultifunctional device 10, the distal end of outer member 68 isintroduced in the body through a narrow portal, which can be astructural channel, an incisional opening or a natural entry. Once theouter member distal end is properly positioned in the body, the flanges78 and 82 are manually grasped and squeezed toward one another causingthe outer member 68 and the inner member 70 to move longitudinallyrelative to one another as permitted by teeth 135 and the spring atjoint 133. Longitudinal movement of outer member 68 and inner member 70toward one another causes the collection bag 72 and spine 74 to beextended beyond the distal end 76 of the outer member 68. Extension ofcollection bag 72 and spine 74 beyond the outer member distal end 76causes spine 74 to automatically move to the expanded position thuslymoving bag 72 to the expanded position. Spine 74 will maintain theexpanded configuration for bag 72, and the distal portion 96 of thesuction cutter will be disposed within the thusly expanded bag 72 asshown in FIG. 10.

The multifunctional device 10 is manipulated from externally of the bodyto position the loop forming portion 16 within the collection bag 72through the opening 73 as shown in FIG. 11. Once the loop formingportion 16 has been positioned in the collection bag 72, the outermember 12 and/or the inner member 14 are rotated relative to oneanother, such as via flanges 22 and 28, it being noted that themultifunctional device in FIG. 11 does not have a U-shaped handle.Rotation of outer member 12 and inner member 14 wrings or twists theloop forming portion 16 thusly squeezing fluids and/or tissue therefromand into bag 72. Accordingly, substances absorbed and/or collected bythe loop forming portion 16 will be released into the collection bag 72and not into the body. When the inlet assembly 125 of the suction cutterassembly 66 is coupled with a source of suction or vacuum, substancesreleased into the collection bag 72 will be drawn through the alignedapertures 102 and 111 and into the lumen 93 of the inner member 92 forwithdrawal from the body. Solid materials drawn through apertures 102and 111 can be cut or miniaturized via movement of one or both of thecutting edges 100 and 108 past one another. In the collection system 62,actuation of the cutting function is accomplished by either squeezinghandle arms 113 and 115 causing relative longitudinal movement of outermember 90 and inner member 92 with concomitant longitudinal movement ofcutting edges 100 and 108 past one another or rotating knob 125 causingrotation of inner member 92 relative to outer member 90 with concomitantrotational movement of cutting edge 108 past cutting edge 100 to cuttissue or other materials positioned in or drawn into apertures 102.

Once substances have been removed from the loop forming portion 16, theloop forming portion 16 can be withdrawn from bag 72, and the tab 77 canbe utilized to close the access slot or opening 73 of the bag to preventrelease of collected substances into the body. It should be appreciatedthat various instruments, such as grasping forceps, can be utilized tograsp and to operate the tab 77. When it is desired to withdraw thecollection system from the body, operating lever 139 is grasped androtated, i.e., counterclockwise looking at FIG. 6, to disengage teeth135 from ridges 137 allowing flanges 78 and 82 to be manually moved awayfrom one another. Movement of flanges 78 and 82 away from one anothercauses relative longitudinal movement of outer member 68 and innermember 70 to position bag 72 and spine 74 in outer member 68 thuslycausing the bag 72 to be moved to the non-expanded position.Accordingly, the outer member 68 presents a uniform profile facilitatingwithdrawal from the body through the narrow portal.

It will be appreciated that the collection bag assembly and the suctioncutter assembly can be built as separate assemblies or as a single unit.The suction cutter can be insertable in the collection bag, permanentlyor removably attached or partially attached to the collection bag orpartly within and/or partly exposed from the collection bag to accessvarious anatomical body cavities and/or structures. The collection bagcan be attached to the suction cutter in many various ways includingattachment to a wall of the suction cutter. In the non-expandedposition, the bag can be wrapped around the suction cutter. Thecollection bag assembly and the suction cutter assembly can include anynumber of elongate members. Various spines can be utilized in thecollection bag assembly including various forceps and tongs. The spinescan be attached to the bag, to the inner member or to some othercomponent of the bag assembly. The bag can have various sizes andconfigurations including conical, oval and toroidal or donut-shapedconfigurations. The collection bag can have various openings, includingoblique openings, and the openings can be provided in the side wall ofthe collection bag or at the forward and/or rearward ends of thecollection bag. Suction through the suction cutter can be controlled viaalignment and non-alignment of the suction cutter apertures, and cuttingcan be accomplished manually or with assisted power, such aselectrically. Suction can be established through the inner member of thesuction cutter or between the outer member and the inner member. Thedistal portion of the suction cutter can be covered by an absorbentmaterial, which can be expandable or non-expandable.

The collection system according to the present invention provides a'single instrument for performing the dual functions of collecting fluidand/or tissue and miniaturizing the collected tissue, and the collectionsystem allows these functions to be performed via a single punctureprocedure. The collection system allows increased quantities ofundesirable fluids and other materials to be evacuated from the bodywithout requiring replacement of the collection bag. Large size tissuespecimens, such as tumors, can be placed in the collection bag withinthe body for miniaturization. The collection system facilitates removalfrom the body of various fluids as well as large size solids through anarrow portal without the need for additional instruments. Thecollection system enhances visualization in the endoscopic procedurebeing performed and permits immediate collection of specimens andfluids. The collection system can be utilized in various space creatingprocedures as well as the removal of lesions by cutting and suction. Thecollection system can be utilized with various other instrumentssuitable for releasing or depositing into the collection bag varioussubstances to be removed from the body.

A modification of a multifunctional device according to the presentinvention is illustrated in FIG. 12 at 210. The multifunctional device210 is similar to the multifunctional device 10, the primary differencesbetween multifunctional device 210 and multifunctional device 10 beingthat loop forming portion 216 for multifunctional device 210 is notdisposed in the outer member 212 in the non-deployed position, and thehandle assembly 218 for multifunctional device 210 does not include aU-shaped handle structure. Loop forming portion 216 includes strips 230having first ends connected to the distal end 220 of outer member 212and second ends connected to the distal end 224 of inner member 214.FIG. 13 illustrates one way of connecting the strips 230 to the outermember 212 and the inner member 214. As shown in FIG. 13, each of thestrips 230 has protruding tabs or fingers 247 at the first and secondends thereof for being received in slots 249 at the distal ends of theouter member 212 and the inner member 214. Slots 249 are open along thecircumferential distal edges of the outer member 212 and the innermember 214, respectively, and extend into the thickness of the wallsforming the outer and inner members.

Handle assembly 218 for multifunctional device 210 includes a transverseflange 222 at a proximal end of outer member 212, a transverse flange228 coupled with inner member 214 and a locking mechanism 242 for fixingthe relative position of flanges 222 and 228. The outer member flange222 is disposed proximally of the inner member flange 228 which iscoupled to the inner member 214 via a pin (not shown) secured to flange228 and to inner member 214 with the pin extending through alongitudinal slot 251 in the outer member 212. Slot 251 is disposedparallel with a longitudinal axis of the multifunctional device 210 topermit longitudinal movement of the outer member 212 and/or the innermember 214 relative to one another in response to squeezing operation offlanges 222 and 228.

Locking mechanism 242 is similar to the locking mechanism for collectionassembly 62 and includes a locking bar 231 pivotally mounted at one endto flange 222 by a joint, pivot or hinge 233. The locking bar 231 isrotationally biased toward flange 228, i.e., clockwise looking at FIG.12, by a torsion spring (not shown) at joint 233. A plurality of lockingteeth 235 are disposed on an upper surface of locking bar 231 along thelength thereof for cooperative engagement with ridges 237 on flange 228.Locking teeth 235 are angled proximally to permit movement of flanges222 and 228 toward one another in response to squeezing operationthereof, and ridges 237 are configured to prevent movement of flanges222 and 228 away from one another upon termination of the squeezingforce. The end of locking arm 231 opposite joint 233 terminates at anangled operating lever 239 for disengaging teeth 235 from ridges 237 topermit movement of flanges 222 and 228 away from one another.

Inlet assembly 256 for multifunctional device 210 can be coupled withouter member 212 or inner member 214 or can be formed as an extension ofthe outer member 212 or the inner member 214. As shown in FIG. 12, theinlet assembly 256 includes a tube 258 coupled with or formed as part ofthe inner member 214 extending proximally of the outer member flange222. Tube 258 includes a valve 260 for selectively opening and closingthe lumen of inner member 214.

Prior to introduction in the body, flanges 222 and 228 are positioned asshown in FIG. 12 such that the distal end 220 of outer member 212 isdisposed proximally of the distal end 224 of inner member 214 a distancecorresponding to the length of strips 230. At this time, loop formingportion 216 will be in the non-deployed position with strips 230extending lengthwise between the distal ends 220 and 224 parallel orsubstantially parallel with one another and with a longitudinal axis ofthe multifunctional device 210. Accordingly, the loop forming portion216 in the non-deployed position forms a uniform profile along a distalportion of the multifunctional device 210 to facilitate introductionthrough a narrow portal.

Use of multifunctional device 210 in endoscopic procedures to performvarious functions in the body is similar to that previously described inthat the distal portion of the multifunctional device 210 is introducedin the body through a narrow portal; and, in the case of multifunctionaldevice 210, it is advantageous for the device to be introduced in thebody through a portal sleeve or cannula or to provide themultifunctional device 210 within an outermost member or sleeve whichcan form part of the device 210 or be separate therefrom. FIG. 12illustrates in dotted lines an outermost elongate member 212' formed aspart of multifunctional device 210 and having an internal lumen orpassage for receiving outer member 212 and terminating proximally at atransverse flange 222' for moving the outermost member 212'longitudinally relative to the outer member 212 to selectively cover andexpose the loop forming portion 216. Accordingly, the multifunctionaldevice 210 can include three, or more, elongate members, and the loopforming portion can be disposed in a protected condition withinoutermost member 212' during introduction in the body through a portal.

Once the loop forming portion 216 is positioned in the body as desired,flanges 222 and 228 are squeezed with one hand causing the flanges 222and 228 to be moved toward one another as permitted by locking teeth 235and the torsion spring at joint 233. If the multifunctional device isprovided with outermost member 212', the flange 222' is moved proximallyto retract outermost member 212' and expose loop forming portion 216prior to operation of handle assembly 218. Movement of flanges 222 and228 toward one another causes concomitant longitudinal movement of outermember 212 and inner member 214. Accordingly, the outer member distalend 220 and the inner member distal end 224 will be moved toward oneanother causing the loop forming portion 216 to be moved to the deployedposition illustrated in FIG. 14. Movement of flanges 222 and 228 iscontrolled via locking teeth 235 and ridges 237 maintaining the flanges222 and 228 and, therefore, the outer member 212 and inner member 214,in a desired position upon termination of the squeezing force on theflanges 222 and 228. When it is desired to extend loop forming portion216 further from the outer member 212 or to move loop forming portion216 to the non-deployed position, operating lever 239 is grasped and isused to rotate the locking bar 231 downwardly, i.e. counterclockwiselooking at FIG. 12, against the upward rotational bias of the torsionspring at joint 233 to disengage teeth 235 from ridges 237. With theteeth 235 and ridges 237 disengaged, flanges 222 and 228 can be movedaway from one another causing relative movement of the outer and innermembers to move loop forming portion 216 toward the non-deployedposition or further toward one another to change the size andconfiguration of loop forming portion 216 in the deployed position.

In the deployed position illustrated in FIG. 14, each of the strips 230has a predetermined configuration, and a spine 253 for guiding thestrips 230 to assume the predetermined configuration is shown in FIGS.15 and 16. FIG. 15 illustrates the predetermined configuration forstrips 230 in the deployed position, only one strip 230 being shown. Inthe deployed position, strip 230 assumes a U-shape configuration and isbent back over itself at a 180° bend with opposite ends of the strip 230extending lengthwise from the bend in the same direction. The strip 230has substantially planar upper and lower surfaces 255 and 257 with athickness therebetween and a width in a direction transverse to alongitudinal axis of the strip 230 that is substantially greater thanthe thickness for increased absorption capability. Spine 253 guidesstrips 230 to assume the predetermined configuration and, as best shownin FIG. 16, includes a length of material having shape memory to benormally disposed in the U-shape configuration. Spine 253 can havevarious cross-sectional configurations and sizes; and, as shown in FIG.16, the spine 253 has a tubular cross-sectional configuration with aminimal outer diameter or size. Where the spine 253 is tubular orhollow, one or more apertures or holes 259 can be provided in the spine253 to permit fluid flow to and from the body through the spine 253.Spine 253 can be arranged on or in the strip 230 in many various ways;and, as shown in FIG. 15, spine 253 is attached to the lower surface 257of the strip 230. Spine 253 is arranged centrally along the width ofstrip 230 and extends along the length thereof, and the ends of spine253 can be attached to the distal ends of the outer member 212 and theinner member 214, or the spine 253 can extend through the outer or innermember. Spine 253 is capable of being unbent or straightened in responseto relative movement of the outer member 212 and the inner member 214allowing strip 230 to be moved to the non-deployed position. Uponmovement of flanges 228 and 222 to deploy loop forming portion 216, theshape memory of spine 253 causes it to return to the normalconfiguration thusly guiding strip 230 to the predeterminedconfiguration corresponding to the normal configuration for spine 253.The spine 253 can be somewhat flexible to flex or give during use, orthe spine 253 can be rigid. Where the spine extends through the device210, the spine can be coupled with an inlet assembly to supply suctionor fluid flow therethrough. Where the spine does not extend through thedevice 210, a passage can be formed through the wall of the outer orinner members communicating with the lumen of the spine, as shown inFIG. 24, and a supplemental conduit can be coupled with the passage forfluid flow through the spine.

In the multifunctional devices according to the present invention, thedirection or orientation of the loop forming portions within the bodycan be adjusted or controlled during use. One way of allowingdirectional adjustment of the loop forming portions in the body is toform one or more of the elongate members with a segment capable ofassuming a predetermined angle, bend or direction. As illustrated inFIG. 17 for the multifunctional device 210, the outer member 212 and theinner member 214 have segments 261 formed with a predetermined bend orangle, only the segment 261 for outer member 212 being visible in FIG.17. Segment 261 includes a portion of the length of outer member 212 andcan be designed in many various ways to normally assume thepredetermined bend or angle. For example, the segment 261 can be made ofa shape memory material or can include a directional bias, hinges orjoints. The segment 261 is designed to be maintained in a straightconfiguration when disposed within the outermost member 212' in thenon-deployed position and to assume the predetermined bent configurationin an adjusted position upon extension of the segment 261 from outermostmember 212'. Accordingly, with the segment 261 in the predetermined bentconfiguration, the loop forming portion 216 will be disposed at an anglewith a longitudinal axis of the multifunctional device 210.

FIGS. 18 and 19 illustrate an adjustment system 265 for moving themultifunctional devices to an adjusted position to change theorientation or direction of the distal portion of the multifunctionaldevices during use where one or both of the elongate members is made offlexible or bendable material. The adjustment system 265 is illustratedin FIGS. 18 and 19 in conjunction with the outer member 212; however, itshould be appreciated that the adjustment system can be utilized withany elongate member forming part of the multifunctional devices.Adjustment system 265 includes left and right control wires 267A and267B extending lengthwise along the outer member 212 within the wallforming outer member 212 or within recesses along an outer surface ofthe wall. Wires 267A and 267B are disposed on opposing lateral sides ofouter member 212 and have distal ends connected with the outer memberdistal end 220 and proximal ends connected with left and right controlwheels 269A and 269B, respectively. Upper and lower control wires 271Aand 271B extend along the outer member 212 at opposing upper and lowersides thereof. Upper and lower control wires 271A and 271B extendthrough the wall forming outer member 212 or within recesses along anouter surface of the wall. Wires 271A and 271B have distal endsconnected with the outer member distal end 220 and proximal endsconnected with upper and lower control wheels 279A and 279B,respectively. Control wheels 269 and 279 can be mounted at variouslocations on the multifunctional device to be easily operated,preferably by the hand grasping the handle assembly, and the controlwheels 269 and 279 can be mounted on the outer member 212 or the handleassembly, for example. The control wires 267 and 271 are movableproximally and distally in response to winding or rotation in a firstdirection of wheels 269 and 279 and in response to unwinding or rotationin a second direction of wheels 269 and 279. Accordingly, the controlwires 267 and 271 are wound or shortened, and unwound or lengthenedaround pins or axles of the control wheels. Movement of one or morewires 267 and 271 by the control wheels results in a corresponding forcebeing applied to outer member 212 due to connection of the wires at theouter member distal end 220. Therefore, winding or pulling of leftcontrol wire 267A in the proximal direction by left control wheel 269Awill cause the distal end 220 to move to the left, looking proximally atFIG. 19, and pulling of right control wire 267B by right control wheel269B will cause the distal end 220 to move to the right. Pulling ofupper and lower control wires 271A and 271B in the proximal direction byupper and lower control wheels 273A and 273B, respectively, will causethe distal end 224 to move up or down. It will be appreciated thatvarious combinations of movements as permitted by the control wires canbe used to adjust the orientation of the elongate member distal end.Distal movement of the control wires via unwinding by the control wheelswill result in reverse movements of the elongate member to straightenthe elongate member longitudinally. The control wheels can be providedwith various mechanisms, such as releasable ratchet mechanisms, forlocking the position of the control wheels to maintain the adjustedposition for the elongate member. It should also be appreciated that thecontrol wires can be operated in various ways in addition to the controlwheels and that more than one directional adjustment can be obtainedwith a single control wheel.

A modification of a multifunctional device according to the presentinvention is illustrated in FIGS. 20 and 21 at 310, the handle assemblyfor the multifunctional device 310 not being shown. Multifunctionaldevice 310 is similar to multifunctional device 210 except that loopforming portion 316 for multifunctional device 310 forms a predeterminedbent configuration in a partially deployed position. Upon movement ofone or both of the outer member 312 and the inner member 314, loopforming portion 316 will be in the partially deployed position whereinstrips 330 are bent outwardly at joints or bend or fold lines 381.Joints 381 are centrally located along the length of strips 330 causingthe strips 330 to protrude or bulge in a direction outwardly of alongitudinal axis of the multifunctional device 310. Joints 381 can beformed as hinges or pivots, which can be formed integrally unitarilywith strips 330 or as separate components. Depending on the materialutilized for strips 330, the opposing ends of strips 330 can bepivotally attached to the distal end 320 of the outer member 312 and thedistal end 324 of the inner member 314 at joints, hinges or pivots. Thestrips 330 can be provided with or without a spine for guiding thestrips 330 to assume the predetermined configuration in the partiallydeployed position shown in FIG. 20. The strips 330 can be designed toassume the predetermined configuration shown in FIG. 20 when in thepartially deployed or intermediate deployed position and to assume apredetermined or non-predetermined full loop configuration, such as thatshown in FIG. 14, when in a fully deployed position upon furthermovement of the outer member 312 and/or the inner member 314.

As shown in FIG. 21, the inner member 314 is provided with one or moreholes or apertures 383 communicating with the lumen of the inner member314. Accordingly, suction can be applied through the lumen of the innermember 314 for withdrawing substances absorbed or collected by the loopforming portion 316, and the suction can be applied in combination withwringing or twisting of the loop forming portion 316 via rotation of oneor both of the outer member 312 and the inner member 314. It should beappreciated that apertures 383 can also be utilized to introduce variousmaterials, such as medicaments, into the body through themultifunctional device 310.

Another modification of a multifunctional device according to thepresent invention is illustrated in FIG. 22 at 410 wherein the handleassembly for multifunctional device 410 is not shown. Multifunctionaldevice 410 is similar to the multifunctional devices previouslydescribed except that loop forming portion 416 for multifunctionaldevice 410 includes a plurality of strips 430 having connecting segments485 extending between the strips 430 and one of the elongate members.Each strip 430 has a first end connected to a distal end 420 of outermember 412 and a second end connected to a distal end 424 of innermember 414 and a connecting segment 485 connected between the strip 430and the outer member distal end 420. The outer member 412 and innermember 414 can be arranged in the non-deployed position to position loopforming portion 416 within the outer member 412 as described formultifunctional device 10 or externally of the outer member 412 asdescribed for multifunctional device 210. Upon relative movement of theouter member 412 and/or the inner member 414, the loop forming portion416 will be moved to the deployed position shown in FIG. 22 wherein theconnecting segments 485 guide, maintain or strengthen the strips 430 toform a predetermined loop configuration. Accordingly, connectingsegments 485 can serve as a re-enforcement or spine for the strips 430.Additionally, the strips 430 can be designed in many various ways, suchas with a shape memory or bias, to be urged away from the connectingsegments 485 in the deployed position creating spaces or interstices 487within the loops formed by strips 430. Accordingly, the strips 430 canform an enlargement or protrusion of increased size and can promoteincreased absorption by loop forming portion 416 as well as increasedcollection of fluid and/or tissue within interstices 487.

Another modification of a multifunctional device according to thepresent invention is illustrated at 510 in FIG. 23 wherein the handleassembly for the multifunctional device 510 is not shown.Multifunctional device 510 includes a loop forming portion 516 made upof a single strip 530 having a first end attached to the distal end 520of outer member 512 and a second end attached to the distal end 524 ofinner member 514. In a non-deployed position, the outer member 512 andthe inner member 514 can be positioned relative to one another toposition the loop forming portion 516 within the outer member 512 orexternally of the outer member 512. In response to relative movement ofone or both of the outer member 512 and inner member 514, the loopforming portion 516 is moved to the deployed position illustrated inFIG. 23 wherein the strip 530 forms a loop, which can be rigid orflexible, to serve as a protruding probe or finger for performingvarious functions in the body.

An additional modification of a multifunctional device according to thepresent invention is illustrated in FIG. 24 at 610 wherein the handleassembly for the multifunctional device 610 is not shown.Multifunctional device 610 includes a loop forming portion 616 made upof a plurality of strips 630 connected between outer member 612 andinner member 614 as previously described. In a deployed position asshown in FIG. 24, the strips 630 assume a multiple loop configuration.During use within the body, one or more of the strips 630 can be cut ordetached; and, as shown in FIG. 24, a first end of one of the strips630' has been detached from its point of connection with the distal end620 of the outer member 612. Strip 630' thusly provides an elongate,distally extending narrow probe for performing various functions andprocedures in the body. As further shown in FIG. 24, the strips 630 eachinclude a passage 689 therethrough which, upon detachment of a strip 630from the outer member 612 or the inner member 614, can be utilized forfluid flow to introduce substances in and to withdraw substances fromthe body via the passage 689. Passages 689' can be provided through thewall of outer member 612 or inner member 614 for communicating withsupplemental conduits, such as that shown in FIG. 29, and with thepassages 689 for allowing flow through device 610 via strips 630.

FIG. 25 illustrates a modification of a multifunctional device 710according to the present invention in combination with a suction cutterassembly 766. Multifunctional device 710 is similar to multifunctionaldevice 10 except that the handle assembly 718 for multifunctional device710 includes flange 722 at a proximal end of outer member 712 and flange728 carried by inner member 714. Flanges 722 and 728 are utilized asdescribed for multifunctional device 210 to move the outer member 712and the inner member 714 relative to one another to move the loopforming portion 716 to the deployed position illustrated in FIG. 25. Itshould be appreciated that the handle assembly 718 can be provided withvarious locking mechanisms, if desired, for fixing the relative positionof the flanges 722 and 728. The inner member 714 terminates proximallyat a knob 726 for rotating the inner member within the outer member towring or twist loop forming portions 716 with the lumen of inner member714 at knob 726 providing an opening for insertion of suction cutterassembly 766. The suction cutter assembly 766 is similar to suctioncutter assembly 66 and includes an outer member 790 and an inner member792 mounted for longitudinal movement relative to one another by handleassembly 794. Additionally, the inner member 792 is mounted for rotationwithin the outer member 790 as obtained via rotation of actuating knob743 carried on the inner member 792.

The suction cutter assembly 766 can be assembled with themultifunctional device 710 prior to introduction in the body at whichtime the loop forming portion 716 will be in the non-deployed positiondisposed within outer member 712, and the distal portion 796 of thesuction cutter assembly will be disposed within the outer member 712.Upon movement of flanges 722 and 728, the loop forming portion 716 willbe moved to the deployed position shown in FIG. 25 thusly exposing thedistal portion 796 of the suction cutter assembly. Accordingly, the loopforming portion 716 forms a configuration of multiple loops disposedabout the suction cutter assembly with the distal portion 796 of thesuction cutter assembly protruding distally from the center of loopforming portion 716. Suction can be applied via the apertures 102 and111 of the suction cutter assembly, and the cutting edges of the distalportion 796 can be utilized to cut anatomical tissue in response torelative movement of the outer member 790 and the inner member 792 viasqueezing operation of handle assembly 794 or via rotational movement ofinner member 792 via knob 743.

A modification of a suction cutter assembly according to the presentinvention is illustrated at 866 in FIG. 26. Suction cutter assembly 866is similar to the suction cutter assemblies previously described exceptthat outer member 890 is covered by a layer of absorbent material 895along distal portion 896. Suction cutter assembly 866 includes outermember 890 terminating distally at a blunt, rounded distal end and innermember 892 disposed in outer member 890 and terminating distally at ablunt, rounded distal end corresponding to the distal end of outermember 890. As best shown in FIG. 27, the distal portion of outer member890 includes a plurality of apertures 902 defining cutting edges 900,and the inner member 892 includes a plurality of apertures 911, normallyaligned with the apertures 902, defining cutting edges 908. Apertures902' and 911' are provided at the distal ends of the outer and innermembers, respectively, define a central passage or channel communicatingwith the lumen of the inner member 892. The layer of material 895includes a plurality of apertures 897 aligned with the apertures 902 inthe outer member 890.

A modification of a handle assembly for use in either themultifunctional devices or collection systems of the present inventionis illustrated at 918 in FIG. 28. Handle assembly 918 is desirable forlongitudinally moving one elongate member relative to another elongatemember and for rotating one elongate member relative to another elongatemember. The handle assembly 918 is described in connection with an outermember 912 and an inner member 914; however, it should be appreciatedthat the handle assembly 918 can be utilized with any elongate membersfor which relative longitudinal movement and/or rotational movement isdesired. Handle assembly 918 includes an elongate hollow housing 997defining a passage for receiving a transverse flange 922 at a proximalend of the outer member 912. The passage in housing 997 is defined by aninternal wall 999 of housing 997 with the wall 999 having aconfiguration corresponding to the peripheral configuration of flange922. A thread 1000 is provided along the internal wall 999 forcooperatively engaging an external thread 1001 along the periphery offlange 922. A transverse flange 928 carried on the inner member 914 isreceived in a recess in a rearward wall of housing 997. The inner member914 terminates proximally at an actuating knob 926 disposed proximallyof housing 997, and a tube 958 of inlet assembly 956 extends into thelumen of inner member 914. Inlet assembly 956 includes a hub 1002 havinga truncated conical configuration disposed in abutment with actuatingknob 926. Hub 1002 has an internal lumen or passage communicating withthe lumen of tube 958 and a valve 960 is coupled with the passagethrough hub 1002.

In use, handle assembly 918 is operated by rotating the housing 997 in afirst direction which causes longitudinal proximal movement of outermember 912 relative to inner member 914 as permitted by threads 1000 and1001. Rotation of the housing 997 in an opposite, second directioncauses longitudinal distal movement of outer member 912 relative toinner member 914. Rotation of housing 997 also causes rotation of outermember 912 relative to inner member 914; and, additionally, the innermember 914 is rotatable relative to the outer member 912 in response torotation of actuating knob 926.

Another modification of a handle assembly for use with themultifunctional devices and collection systems of the present inventionis illustrated at 1018 in FIG. 29. The handle assembly 1018 isillustrated in conjunction with an outer member 1012 and an inner member1014; however, it should be appreciated that the handle assembly 1018can be utilized with any elongate members of the multifunctional devicesand collection systems of the present invention. Handle assembly 1018 issimilar to handle assembly 218 except that the locking mechanism 1042for the handle assembly 1018 includes a pair of pivotable locking bars1044. Handle assembly 1018 includes a transverse flange 1022 carried byouter member 1012 and a transverse flange 1028 carried by inner member1014. An inlet assembly 1056 is coupled with the lumen of inner member1014 and includes a tube 1058 extending into or formed as part of theinner member 1014, a valve 1060 for opening and closing the lumen ofinner member 1014 and a supplemental conduit 1003 extending through awall of inner member 1014 or a wall of tube 1058 for communicating withthe lumen of the inner member 1014. The conduit 1003 is provided with avalve 1004 for controlling flow therethrough and, therefore, through thelumen of inner member 1014. The locking mechanism 1042 for handleassembly 1018 includes a pair of locking bars 1044 pivotally attached toflange 1022 at pivots, hinges or joints 1046. Joints 1046 are disposedat opposing lateral sides of flange 1022, and the joints 1046 can beprovided with torsion springs (not shown) for rotationally biasing thelocking bars 1044 inwardly in the direction of a longitudinal axis ofthe inner member 1014. With the locking bars 1044 rotated or biasedinwardly about joints 1046, ends of the locking bars 1044 opposite thejoints 1046 will engage flange 1028 to prevent movement of flanges 1022and 1028 toward one another and thusly establishing an initial positionfor elongate members 1012 and 1014. When it is desired to operate handleassembly 1018 to move outer member 1012 relative to inner member 1014,the locking bars 1044 are pivoted or rotated outwardly about joints 1046to disengage the ends from flange 1028 at which time the flanges 1022and 1028 can be moved toward one another thusly moving the outer member1012 and the inner member 1014.

Inasmuch as the present invention is subject to many modifications,variations and changes in detail, it is intended that all subject matterdiscussed above or shown in the drawings be interpreted as illustrativeonly and not to be taken in a limiting sense.

What is claimed is:
 1. A collection system for collecting substances inthe body of a patient in operative procedures wherein access to aninternal site in the patient's body is gained through a narrow portal inthe patient's body comprisinga collection bag assembly including anelongate inner tubular member having a distal end and a proximal end, anelongate outer tubular member slidably receiving said inner tubularmember and having a distal end and a proximal end, said distal ends ofsaid inner and outer tubular members being introducible at the internalsite in the patient's body through the narrow portal with said proximalends of said inner and outer tubular members disposed externally of theinternal site, said proximal ends of said inner and outer tubularmembers being connected to one another while allowing longitudinalmovement of said inner and outer tubular members relative to oneanother, and a collection bag carried by said distal end of said innertubular member and having an interior for holding substances, saidcollection bag being disposed in said outer tubular member in anon-expanded position when said distal end of said outer tubular memberis introduced at the internal site in the patient's body through thenarrow portal, said collection bag being movable from said non-expandedposition to an expanded position following introduction of said distalend of said outer member at the internal site within the patient's body,said collection bag in said expanded position being disposed externallyof said outer tubular member to allow substances to be introduced insaid interior of said collection bag within the patient's body, at leastone of said outer and inner tubular members being movable longitudinallyrelative to the other of said outer and inner tubular members to movesaid collection bag externally of said outer tubular member whereby saidcollection bag is moved from said non-expanded position to said expandedposition; and a suction cutter assembly including a suction cutterdisposed in said inner tubular member, said suction cutter having adistal end disposed in said interior of said collection bag, a proximalend disposed externally of the internal site and a suction channelbetween said distal and proximal ends of said suction cutter, saidproximal end of said suction cutter being connectable with a source ofsuction for withdrawing substances introduced in said interior of saidcollection bag from the patient's body, said suction cutter beingcoupled with said collection baa assembly for introduction of saiddistal end of said suction cutter at the internal site in the patient'sbody simultaneously with said collection bag.
 2. A collection system asrecited in claim 1 wherein said suction cutter includes an outer tubularmember having a distal cutting edge and an inner tubular member receivedin said outer tubular member of said suction cutter and having a distalcutting edge cooperating with said distal cutting edge of said outertubular member of said suction cutter to cut substances introduced insaid interior of said collection bag, said inner tubular member of saidsuction cutter having a lumen therethrough forming said suction channel.3. A collection system as recited in claim 2 and further including atleast one aperture in said outer tubular member of said suction cutter,said aperture being circumscribed by said distal cutting edge of saidouter tubular member of said suction cutter, and at least one aperturein said inner tubular member of said suction cutter, said aperture insaid inner tubular member of said suction cutter being circumscribed bysaid distal cutting edge of said inner tubular member of said suctioncutter, said aperture in said inner tubular member of said suctioncutter communicating with said lumen and with said interior of saidcollection bag.
 4. A collection system as recited in claim 3 and furtherincluding a handle at said proximal end of said suction cutter formoving at least one of said distal cutting edges relative to the otherof said distal cutting edges to cut substances drawn by suction throughsaid apertures and into said lumen.
 5. A collection system as recited inclaim 4 wherein said distal end of said outer tubular member of saidsuction cutter is covered with a layer of absorbent material having atleast one aperture aligned with said at least one aperture in said outertubular member of said suction cutter.
 6. A collection system as recitedin claim 1 and further including a flexible spine for guiding saidcollection bag to said expanded position.
 7. A collection system asrecited in claim 1 wherein said collection bag has an access slottherein communicating with said interior allowing substances to beintroduced in said collection bag through said access slot.
 8. Acollection system as recited in claim 7 wherein said access slotincludes a slide closure for selectively opening and closing said accessslot within the patient's body.